Regulatory Affairs Certification (RAC) Practice Exam

In which scenario does a company NOT need to submit to CBER?

1. For live vaccines

2. For in vivo treatments with monoclonal antibodies

3. For biosimilars in clinical trials

4. For investigational use of monoclonal antibodies in vitro

The correct answer is: For investigational use of monoclonal antibodies in vitro

The scenario where a company does not need to submit to the Center for Biologics Evaluation and Research (CBER) involves investigational use of monoclonal antibodies in vitro. This is primarily because CBER's oversight typically applies to products intended for human use, particularly those involving administration to patients, such as therapies or products that are meant to have a physiological effect on the human body. When monoclonal antibodies are used for in vitro purposes, such as laboratory research or diagnostic procedures, they do not enter into the realm of clinical investigation as defined by regulatory standards. Therefore, they are not subject to the same submission requirements that would apply to products that are intended for use in patients or in vivo applications. In contrast, scenarios involving live vaccines, in vivo treatments, and biosimilars in clinical trials require regulatory oversight by CBER. These scenarios entail direct interaction with human subjects or involve products that significantly impact health outcomes, necessitating the rigorous evaluation and monitoring process that CBER provides to ensure safety and efficacy.